dha-paclitaxel in treating patients with metastatic pancreatic cancer

Conditions: Pancreatic Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of dha-paclitaxel in treating patients who have metastatic pancreatic cancer.

objectives: * determine the tumor response rate, duration of response, and time to disease progression in patients with metastatic carcinoma of the pancreas treated with dha-paclitaxel. * determine the overall survival of patients treated with this drug. * determine the toxicity profile of this drug in these patients. * assess the quality of life of patients treated with this drug. outline: this is a multicenter study. patients receive dha-paclitaxel iv over 2 hours on day 1. treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. quality of life is assessed at baseline, every 2 courses, and at completion of treatment. patients are followed every 3 months. projected accrual: a total of 21-50 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed carcinoma of the pancreas * metastatic disease * measurable disease * lesions within a previously irradiated field are not considered measurable * no islet cell tumors, lymphoma, or sarcoma of the pancreas * no known or clinical evidence of cns metastasis patient characteristics: age: * 18 and over performance status: * ecog 0-1 life expectancy: * not specified hematopoietic: * absolute neutrophil count at least 1,500/mm\^3 * platelet count at least 100,000/mm\^3 hepatic: * bilirubin no greater than 1.5 times upper limit of normal (uln) * sgot or sgpt no greater than 2.5 times uln renal: * creatinine no greater than 1.5 times uln cardiovascular: * no uncontrolled ventricular arrhythmia * no myocardial infarction within the past 3 months * no superior vena cava syndrome neurologic: * no peripheral neuropathy greater than grade 1 * no uncontrolled major seizure disorder * no spinal cord compression other: * no concurrent serious infection requiring parenteral therapy * no unstable or serious concurrent medical condition * no other prior malignancy except: * curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix or * other cancer curatively treated with surgery alone that has not recurred for more than 5 years * no psychiatric disorder that would preclude study compliance * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception during and for 6 months after study therapy prior concurrent therapy: biologic therapy: * no concurrent immunotherapy chemotherapy: * no prior chemotherapy for metastatic disease * prior adjuvant chemoradiotherapy allowed * at least 28 days since prior chemotherapy and recovered * no other concurrent chemotherapy endocrine therapy: * no concurrent hormonal therapy except megestrol radiotherapy: * see disease characteristics * prior adjuvant chemoradiotherapy allowed * at least 28 days since prior large-field radiotherapy and recovered * no concurrent radiotherapy surgery: * at least 14 days since prior major surgery and recovered other: * no other concurrent anticancer therapy

Keywords: recurrent pancreatic cancer stage iv pancreatic cancer